SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM— 510(k) K103340
Substantially EquivalentHarvest Technologies, Corp.
FDA 510(k) clearance K103340 for SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM, Substantially Equivalent on 2010-12-06. Applicant: Harvest Technologies, Corp.. Device class: 1.
Clearance details
- Applicant
- Harvest Technologies, Corp.
- Product code
- Code JQC
- Device class
- Class 1
- Regulation
- 21 CFR 862.2050
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Plymouth, MA, US
Recent devices under product code JQC
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More clearances from Harvest Technologies, Corp.
view allAdverse events under product code JQC
product code JQC- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K103340
K-number listed on FDA's recall record- Z-0103-2018 — HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO
- Z-0104-2018 — HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K103340.
Data sourced from openFDA. This site is unofficial and independent of the FDA.